BEUDAMED
    FDA Adverse Event Death Summary report: N

    2000 ML LINER W/LID&POUR SPOUT

    MDR report key: 1060864 · Received June 10, 2008

    Report

    Report Number
    3005515211-2008-00004
    Event Type
    Death
    Date Received
    June 10, 2008
    Date of Event
    May 10, 2008
    Report Date
    May 12, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    GCX
    PMA / PMN Number
    K893741
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR INVESTIGATION. IF THE DEVICE IS REC'D, A F/U REPORT WILL BE SUBMITTED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED LOSS OF SUCTION. IT WAS REPORTED THAT AT AN UNSPECIFIED TIME WHILE THE PT WAS BEING FED, THE PT ASPIRATED. A RESPIRATORY CODE WAS INITIATED AND THE PT WAS SUCTIONED. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE SUCTION REPORTEDLY STOPPED. THE SUCTION LINER AND CANISTER WERE REPLACED. APPROX 5 MINS LATER, SUCTIONING WAS RESUMED. IT WAS REPORTED THAT THE PT WAS "VERY ILL" AND AFTER AN UNSPECIFIED LENGTH OF TIME THE PT EXPIRED. SUBSEQUENT TO THE EVENT, THE FIRST LINER WAS EXAMINED BY STAFF AT THE USER FACILITY AND A HOLE WAS NOTED IN THE LINER. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2000 ML LINER W/LID&POUR SPOUT 79-GCX GCX HOSPIRA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death